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MakroCare Clinical QA Job For BS & MSc – Apply Online
Quality Assurance (Clinical QA) – Associate
Location: Hyderabad, Telangana, India
About the Job
Department: QA – MakroCare and DDi
Job Roles and Responsibilities
- Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations.
- Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed.
- Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads.
- Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements.
- Conduct internal audits of Clinical Research Department activities and ISO requirements, ensuring compliance with ICH-GCP and company procedures.
- Provide training to staff on ISO standards and local regulations when necessary.
- Control and manage documents, including maintaining master lists and issuing change controls, deviations, CAPAs, amendments, and notes to file.
- Update logs for change control, deviations, CAPAs, amendments, and NTFs.
- Prepare annual CQA reports and trend analysis, and assist with external audits from clients, certification bodies, or regulatory authorities.
Requirements
- Education: Bachelor’s or Master’s in Life Sciences (or related field).
- Experience: 3-5 years of experience in Clinical Quality Assurance or related roles.
- Familiarity with ISO regulations, ICH-GCP guidelines, and QMS.
- Experience in conducting internal audits and maintaining regulatory documentation.
Note: Additional responsibilities may be assigned by the Head of Department (HOD).
Skills
- ISO standards
- GCP
- ISO regulations
- Quality assurance
- Clinical quality assurance
- Quality Management System (QMS)
- ICH-GCP
- Training
- Regulatory documentation
- Internal audits
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